What is the NaviFUS System studying for drug-resistant epilepsy?

The NaviFUS System is being studied to evaluate its safety and early effectiveness in reducing seizures in patients with drug-resistant temporal lobe epilepsy. This study aims to see if focused ultrasound can safely decrease abnormal brain activity related to seizures. The research is sponsored by NaviFUS Corporation to explore new options for patients whose seizures do not respond well to medications.

Who may be eligible for this drug-resistant epilepsy clinical trial?

Adults aged 18 and older with drug-resistant temporal lobe epilepsy may be eligible. Participants must have focal seizures with no more than two seizure onset zones, be on stable anti-epileptic medications, and able to complete study requirements in English. Please review eligibility criteria for more details.

Is there any cost to participate in this drug-resistant epilepsy clinical trial?

Study-related care, including the study device treatment and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06388707

Pilot Study of Low-intensity Focused Ultrasound Neuromodulation for Safety and Early Effectiveness in Adults with Drug-Resistant Temporal Lobe Epilepsy

Led by NaviFUS Corporation · Updated on 2026-04-09

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of low-intensity focused ultrasound LIFU neuromodulation using the NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy DR-TLE. This pilot study involves adults with epilepsy that has not responded to standard medications, aiming to reduce abnormal brain activity and seizures. Participants will undergo six LIFU treatment sessions over three consecutive weeks. Each treatment uses specific ultrasound exposure settings delivered by the NaviFUS System. Before treatment, patients will be observed and asked to keep a seizure diary for 8 weeks. After completing treatments, there is a 12-week follow-up period to monitor outcomes. Patients may continue their anti-seizure medications throughout the study. Participants will keep a seizure diary throughout the study to track seizure frequency and severity. Researchers will also assess safety by monitoring adverse events for up to 23 weeks. Additional evaluations include EEG scans to observe changes in brain activity, and questionnaires that measure anxiety, depression, and the personal impact of epilepsy. The total study duration includes a 2-month baseline, 3 weeks of treatment, and 12 weeks of follow-up.

CONDITIONS

Brief Title

A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female patients 18 years of age or older at the time of enrollment
Diagnosed with drug-resistant temporal lobe epilepsy, defined by failure of adequate trials of two tolerated anti-epileptic drug schedules
Have focal-onset seizures with no more than two seizure onset zones, at least one in the mesial temporal lobe
Experienced at least 4 focal-onset seizures with disabling manifestations in the 8-week baseline and at least one seizure per month
Have MRI and EEG within the past 3 years, with at least one EEG showing focal epileptiform findings
Central focused ultrasound exposure region located at least 30 mm beneath the skull bone
On stable anti-epileptic drug regimen for at least 30 days before enrollment
Females of childbearing potential must test negative for pregnancy before first treatment and agree to effective contraception during the study
Able and willing to have hair shaved where the treatment device will be applied
Able to complete all study questionnaires in English, including with interpreter if needed
Able to provide informed consent and comply with study requirements

You will not qualify if you...

Primary generalized epilepsy, mixed focal and generalized epilepsy, or history of non-epileptic seizures
Experienced tonic-clonic status epilepticus within 12 months before enrollment
Sonication pathway blocked by scars, scalp disorders, metallic implants, or prior craniotomy
Acute or progressive neurological disorders such as brain tumor, multiple sclerosis, dementia, or vascular lesions
Implanted electronic devices like pacemakers, defibrillators, deep brain stimulation, except for stable Vagus Nerve Stimulators
Severe depression, active suicidal behavior, active psychosis, or psychiatric hospitalization within past year
IQ below 70 based on standardized intelligence testing
Medical problems limiting study compliance or data interpretation
Participation in other investigational drug or device studies within 4 weeks before treatment
Radiofrequency thermocoagulation treatment within 2 months before enrollment
History of substance or alcohol abuse within the past year (except marijuana)
Pregnant or breastfeeding women
Any other condition judged to increase risk or affect study endpoints by the Investigator

Research Team

Sheang-Tze Fung, Ph.D.

Arthur Lung, Ph.D.

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